Evaluation of Oral Toxicity of Palatinose/Fructooligosaccharide and Palatinose/Invert Sugar in Sprague-Dawley Rats.

An evaluation of the safety profile of palatinose/fructooligosaccharide (P/FOS) and palatinose/invert sugar (P/IS), as novel low-glycemic and functional sweetener combinations, is essential for their application. This study aimed to evaluate the safety of 1000 mg/kg/day of P/FOS and 1000 mg/kg/day of P/IS through a 14-day repeated-dose oral toxicity study using male and female Sprague-Dawley (SD) rats. Clinical signs, such as body weight and organ weights, food/water consumption, hematology results, blood biochemical analysis results, urinalysis results, and histological changes in the liver and kidneys, were recorded in all SD rats. Barely any significant changes in food/water consumption, body weight, and organ weight were observed during the experimental period. Although there were some alterations in the results of hematological analysis, serum biochemical analysis, and urinalysis, these changes were not considered toxicologically significant within the normal ranges in both male and female SD rats administered with P/FOS and P/IS at 1000 mg/kg/day. Additionally, a histopathological analysis of the liver and kidneys showed no toxicological changes in P/FOS- and P/IS-treated SD rats of both sexes at the tested dose. Collectively, the above results confirmed that no overt treatment-related adverse effects of P/FOS and P/IS were observed under the tested conditions.